FDA — authorised 24 July 1957
- Application: NDA011073
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: WAMPOCAP
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Nicotinic Acids in United States
FDA authorised Nicotinic Acids on 24 July 1957
Marketing authorisations
FDA — authorised 15 September 1972
- Application: ANDA083180
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 1973
- Application: ANDA083136
- Marketing authorisation holder: WATSON LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 1973
- Application: ANDA083525
- Marketing authorisation holder: MK LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1973
- Application: ANDA083823
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: NICOLAR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 1974
- Application: ANDA083718
- Marketing authorisation holder: HIKMA
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 February 1982
- Application: ANDA085172
- Marketing authorisation holder: WATSON LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1992
- Application: ANDA081134
- Marketing authorisation holder: WOCKHARDT
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 1997
- Application: NDA020381
- Marketing authorisation holder: ABBVIE
- Local brand name: NIASPAN TITRATION STARTER PACK
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2005
- Application: ANDA076250
- Marketing authorisation holder: BARR
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 April 2005
- Application: ANDA076378
- Marketing authorisation holder: BARR
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090860
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090892
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2014
- Application: ANDA090446
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 April 2014
- Application: ANDA201273
- Marketing authorisation holder: SUN PHARM
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 April 2014
- Application: ANDA200484
- Marketing authorisation holder: SUN PHARM
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 July 2015
- Application: ANDA203578
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 December 2015
- Application: ANDA204178
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 May 2018
- Application: ANDA209156
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA203742
- Marketing authorisation holder: RISING
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 June 2019
- Application: ANDA212017
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 November 2021
- Application: ANDA214428
- Marketing authorisation holder: BEIJING
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 March 2022
- Application: ANDA204934
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 August 2023
- Application: ANDA213090
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA203285
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 July 2025
- Application: ANDA207726
- Marketing authorisation holder: MPP PHARMA
- Local brand name: NIACIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA083453
- Marketing authorisation holder: HALSEY
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084237
- Marketing authorisation holder: TABLICAPS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083115
- Marketing authorisation holder: IMPAX LABS
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083203
- Marketing authorisation holder: EVERYLIFE
- Local brand name: NIACIN
- Indication: TABLET — ORAL
- Status: approved
Nicotinic Acids in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Nicotinic Acids approved in United States?
Yes. FDA authorised it on 24 July 1957; FDA authorised it on 15 September 1972; FDA authorised it on 4 January 1973.
Who is the marketing authorisation holder for Nicotinic Acids in United States?
MEDPOINTE PHARM HLC holds the US marketing authorisation.